Evaluation of a neuroprosthesis for improving mobility in paralyzed individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a surgically implanted functional electrical stimulation (FES) system designed to enhance exercise, standing, stepping, and balance in individuals with varying degrees of paralysis. Participants will undergo surgery to implant electrodes into the muscles of the trunk and legs, which are connected to a stimulator. Following implantation, patients will receive training in mobility skills using the FES system, along with a prescribed rehabilitation program. The study includes assessments of strength, balance, and functional abilities at multiple follow-up points after discharge.

Why it matters

Who can join: the full rules

Phase I Inclusion Criteria

1. Skeletal maturity and ability to sign informed consent (\>18 years)
2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
3. Innervated and excitable lower extremity and trunk musculature
4. Adequate social support and stability
5. Willingness to comply with follow-up procedures

Phase I Exclusion Criteria

1. Non-English speaking
2. Females who are pregnant
3. Current pressure injuries that would be exacerbated by study activities
4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
5. History of spontaneous fractures or other evidence of excessively low bone density
6. History of vestibular dysfunction, balance problems, or spontaneous falls
7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.

Where it's running

• Louis Stokes Cleveland VA Medical Center
  Cleveland, Ohio, United States Recruiting
• MetroHealth System
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Ronald J Triolo, Ph.D. — Case Western Reserve University
• Study coordinator: Lisa M Lombardo, MPT
• Email: lisa.lombardo2@va.gov
• Phone: 216-791-3800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.